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A Phase I Trial of Adoptive Cell Therapy With Tumor-Infiltrating Lymphocytes and ANV419 in Patients With Advanced Melanoma. The BaseTIL-03M Trial
In this study we aim to investigate safety and tolerability of tumor-infiltrating lymphocytes (TIL) adoptive cell therapy (ACT) incorporation in-vivo TIL expansion with ANV419 in patients with advanced melanoma
Details
| Lead sponsor | University Hospital, Basel, Switzerland |
|---|---|
| Phase | Phase 1 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 10 |
| Start date | 2023-06-21 |
| Completion | 2026-06 |
Conditions
- Advanced Melanoma
Interventions
- Combination of Tumor-infiltrating lymphocyte transfer with ANV419
Primary outcomes
- Incidence of adverse events (%) — up to one year after TIL transfer
Incidence of adverse events (%) will be recorded to assess safety of combination of Tumor-infiltrating lymphocytes with ANV419 - Frequency of adverse events (number) — up to one year after TIL transfer
Frequency of adverse events (number) will be recorded to assess safety of combination of Tumor-infiltrating lymphocytes with ANV419 - Severity of adverse events (CTCAE v5.0 criteria) — up to one year after TIL transfer
Severity of adverse events (CTCAE v5.0 criteria) will be recorded to assess safety of combination of Tumor-infiltrating lymphocytes with ANV419. CTCAE (Common Terminology Criteria for Adverse Events): Grade 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = fatal.
Countries
Switzerland